ZOLEDRONIC ACID FOR INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

متاح من:

FRESENIUS KABI CANADA LTD

ATC رمز:

M05BA08

INN (الاسم الدولي):

ZOLEDRONIC ACID

جرعة:

4MG

الشكل الصيدلاني:

SOLUTION

تركيب:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

5ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BONE RESORPTION INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0141761002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2014-11-13

خصائص المنتج

_ _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
Bone Metabolism Regulator
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
May 26, 2017
Submission Control No: 205586
_ _
_Zoledronic Acid for Injection-PM-ENG-v6.0 _
_ _
_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
................................................................................34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.............................................................................................